Clincosm LogoSign in Get a demo

MOGLYCC: Monitoring of Glycocalyx for Prediction of Complications After Cardiac Surgery

Sponsor
University Hospital, Rouen (Other)
Overall Status
Recruiting
CT.gov ID
NCT06136637
Collaborator
University of Rouen Normandie (Other)
77
Enrollment
1
Location
25
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective observational study of the evolution of the microcirculation and the sublingual glycocalyx in perioperative cardiac surgery under cardiopulmonary bypass. Our main objective is to evaluate the prognostic value of the variation of the thickness of the perioperative glycocalyx for the occurrence of a major complication in the first 24 hours after surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    77 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation de l'utilité du Monitorage du Glycacalyx Pour prédire Les Complications du Patient de Chirurgie Cardiaque
    Actual Study Start Date :
    Jun 1, 2022
    Anticipated Primary Completion Date :
    Jul 1, 2024
    Anticipated Study Completion Date :
    Jul 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Glycocalyx thickness variation [Two hours after the end of cardiopulmonarybypass]

      Change in glycocalyx thickness between the preoperative period and the postoperative period (2 hours after the end of cardiopulmonary bypass).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • Patient of legal age (age ≥ 18 years)

    • Patient undergoing scheduled cardiac surgery with cardiopulmoary bypass (CPB) (expected duration of CPB > 60 min)

    • Person informed with collection of non-opposition at the latest, the day before the operation - Person affiliated to a social security system

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rouen University Hospital Rouen France

    Sponsors and Collaborators

    • University Hospital, Rouen
    • University of Rouen Normandie

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DEMAILLY Zoe, Principal Investigator, University Hospital, Rouen
    ClinicalTrials.gov Identifier:
    NCT06136637
    Other Study ID Numbers:
    • 2021-A02377-34
    • 2020/416/OB
    First Posted:
    Nov 18, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by DEMAILLY Zoe, Principal Investigator, University Hospital, Rouen
    Glycocalyx
    Microcirculation
    Cardiopulmonary bypass
    Organ failure

    Study Results

    No Results Posted as of Nov 18, 2023